10.16.24 -- Your CDMO's Maintenance, From Roof To Floor And Ever More

Join Ropack on October 23rd as we explore how outsourcing can facilitate access to advanced equipment, streamline production scaling, and minimize risks related to supply chain disruptions and regulatory challenges. Whether considering outsourcing or currently engaging in outsourcing, we will provide valuable insights to help you make informed decisions that align with your operational and strategic goals.

The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.

Safe handling of HPAPIs is complex and the associated regulatory requirements are growing. Discover how leveraging a CDMO can ensure treatments reach patients faster, safely, and cost-effectively.

Although there is no universal solution to boost supply chain versatility for all organizations, following three crucial steps can aid CMOs in realizing the advantages of greater flexibility.

Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.

Utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.

Our network currently spans across nine manufacturing sites in five countries and can support discovery, preclinical, clinical and commercial programs for New Chemical Entities (NCEs).

Learn how the right partner can leverage years of experience, market knowledge, industry relationships, and clinical packaging expertise to develop a sourcing strategy tailored to the needs of each study.